Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria (CAB)
Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.
The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring catheters.
調査の概要
詳細な説明
Urinary tract infection (UTI) is the most common healthcare associated infection (HAI) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the United States, of which 75% are associated with indwelling urinary catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs.
The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring catheters for more than 72 hours. This study will also evaluate the efficacy in reducing bacteriuria of the Accuryn silver fabricated silicone catheters.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adult (age ≥ 18)
- Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent
- Indication for a urinary bladder catheter (or one currently in place)
- Expected urinary catheter requirement ≥ 72 hours
- No current urinary tract infection
- No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours
Exclusion Criteria:
- Inability to receive a urinary bladder catheter
- Chronic suprapubic catheter in place
- Expected survival < 72 hours
- Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery
- Surgery of the genitourinary tract in the past 6 months prior to admission
- Deemed unfit for the protocol by the investigator for any reason
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Standard of Care
Patients will receive Standard of Care, commercially available catheter utilized by hospital system.
|
Standard of care urinary drainage system.
|
|
実験的：Drain Line Clearance (DLC) Group
Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter.
|
Urinary drainage system with active drain line clearance and plain silicone catheter.
|
|
実験的：Drain Line Clearance and Silver (DLCS) Group
Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter.
|
Urinary drainage system with active drain line clearance and silver-doped silicone catheter.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in percentage of catheter-associated bacteriuria
時間枠：30 days
|
To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance.
|
30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria
時間枠：30 days
|
To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
|
30 days
|
|
Time to Bacteriuria (ASB and CAUTI)
時間枠：30 days
|
To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
|
30 days
|
|
Urine Culture Comparisons
時間枠：30 days
|
To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag).
|
30 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Kevin Foster, MD、Maricopa Integrated Health System (MIHS)
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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